BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GAMMA CAMERA

    MDR report key: 423 · Received April 17, 1992

    Report

    Report Number
    423
    Event Type
    Malfunction
    Date Received
    April 17, 1992
    Date of Event
    February 21, 1992
    Report Date
    April 8, 1992
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS OF AMERICA
    Product Code
    IYX
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT "A" HAD A WHOLE BODY BONE SCAN ON FEBRUARY 14, 1990 WITHOUT INCIDENT. THE STUDY WAS HARD COPIED WITH THE MULTIFORMAT CAMERA AND DICTATED THAT DAY. ON FEBRUARY 21, 1990 PATIENT "B" HAD A WHOLE BODY BONE SCAN. THE STAFF HARD-COPIED THE STUDY ON FEBRUARYA 21, 1990 AND THE STUDY WAS INTERPRETED BY THE RADIOLOGIST. IN JANUARY 1992, WE WERE TOLD THAT THE FILMS HAD BEEN MIXED UP AND NOT PROPERLY REPORTED. THE LEAD NUCLEAR MACHINE TECHNOLOGIST REPORTED THE POTENTIAL PROBLEM TO THE FRED NELSON, TOSHIBA AREA NUCLEAR MEDICINE SPECIALIST. WE WERE TOLD THAT IT WAS NOT POSSIBLE. ON MARCH 12, 1992, THE RADIOLOGIST REVIEWED THE STUDIES OF ALL BONE SCANS DONE IN FEBRUARY 1990. DURING THIS AUDIT, HE DISCOVERED THAT PATIENT "A"'S WHOLE BODY SCAN IMAGES WERE IDENTIFIED AS PATIENT "B"'S STUDY. ONLY THE COMPUTER PROCESSED IMAGES WERE AFFECTED. THE SPOT FILMS WERE OF THE CORRECT PATIENT. THERE WERE NO SIMILARITIES IN THE PATIENT'S NAMES, EXAMINATION NUMBER, MEDICAL RECORD NUMBER, OR DESCRIPTION. MANUFACTURER HAS BEEN NOTIFIED. WE FEEL THAT HUMAN ERROR IS HIGHLY IMPROBABLE DUE TO THE MANNER THAT THE FILES ARE RETRIEVED FOR HARD COPY AND PROCESSING. THE UNIT'S HARD DISC AND SOFTWARE HAS BEEN UPDATED SINCE THE INCIDENTDEVICE NOT LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.DEVICE SERVICED IN ACCORDANCE WITH SERVICE SCHEDULE. DATE LAST SERVICED: 01-FEB-90. SERVICE PROVIDED BY: MANUFACTURER. SERVICE RECORDS AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: COMPUTER OPERATING SYSTEM SOFTWARE, COMPUTER SOFTWARE PROBLEM, INVALID DATA. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT, DEVICE FAILURE DIRECTLY CAUSED EVENT, SOFTWARE/FIRMWARE CONTRIBUTED TO EVENT, DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE USE CONTINUED WITH RESTRICTIONS/LIMITATIONS, USER EDUCATION PROVIDED. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GAMMA CAMERA IYX TOSHIBA MEDICAL SYSTEMS OF AMERICA GCA-901A IMAGING SYSTEM N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other